An interventional study of MASP+ and Control in Cigarette Smoking, sponsored by University of Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by University of Houston · Not applicable, Interventional, and Treatment
The present investigation aims to address disparities in cigarette use outcomes among Black/African American adults with HIV. The specific aims of this study are: (1) To modify a recently developed, culturally adapted, mobile application for Black smokers by integrating information specifically relevant to Black persons with HIV/AIDS. (2) To conduct a randomized clinical trial for anxiety-sensitivity reduction and cigarette cessation among Black smokers with HIV.
The current trial aims to refine and conduct a comprehensive cultural and HIV-sensitive adaptation of an initially tested, novel mobile intervention (MASP+) targeting anxiety sensitivity (AS) among Black/African American (daily) cigarette users with HIV/AIDS. The MASP+ app prompts users remotely throughout the day to assess mood symptoms, cigarette cravings or nicotine withdrawal symptoms, and general mental health. When respondents indicate they are struggling with cigarette urges or cravings, or if they are experiencing heightened levels of stress or anxiety, the app selects and delivers a tailored message from a library of messages and videos.
The MASP+ app has the potential to deliver highly effective and accessible treatment to a highly underserved subpopulation within the Black community considered to be at exceptionally high risk of smoking problems (social, psychological, physical) and smoking relapse.
114 studies on the registry are indexed under Cigarette Smoking; 59 are open to participants now.
This study's enrollment of 76 is below the median of 100 across 101 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →University of Houston is the lead sponsor of 101 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
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Exclusion Criteria:
MASP+ is an intervention designed to assist Black smokers with HIV who experience elevated anxiety sensitivity to quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal. Nicotine patches will be made available to provide adjunctive support.
Behavioral: MASP+
The QuitGuide app is a standard-of-care app that allows users to track nicotine cravings and provides motivational messages. Nicotine patches will be made available to provide adjunctive support.
Behavioral: Control
mHealth (mobile app) for smoking cessation
A mobile app designed to assist the general population with smoking cessation.
Also known as: National Cancer Institute (NCI) QuitGuide app
Biochemically Verified Smoking Abstinence
Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 weeks following the scheduled quit day. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of \< 7 ppm. Those with scores of 6 or below are biochemically confirmed to be abstinent.
Time frame: Weeks 2,3,4,5,6, & 28
Index of Engagement in HIV Care
The Index of Engagement in HIV Care is a brief (10-item) self-report measure of engagement in human immunodeficiency virus (HIV) care. The total score is used to index engagement in HIV care, ranging from 10-50. Higher scores indicate greater engagement in HIV care.
Time frame: Weeks 28
World Health Organization Quality of Life HIV (WHOQOL-HIV)
The World Health Organization Quality of Life HIV (WHOQOL-HIV) questionnaire is composed of 36 items and is used to index quality of life among respondents living with HIV/AIDS. The study use three subscales of the WHOQOL-HIV (physical domain \[range: 4-20\], psychological domain \[range: 4-25\], social relationships domain \[range: 4-20\]). All subscales are averaged and multiplied by 4. Higher scores on each substance indicate greater quality of life within the respective domain.
Time frame: Weeks 28
Antiretroviral (ART) Adherence
The 3-item Antiretroviral (ART) Adherence questionnaire is a brief scale used to assess frequency of missed ART medication doses and HIV care appointments among HIV+ patients/participants. The scale is averaged to create a score of ART adherence (range: 0-100), with greater scores indicate greater ART medication adherence.
Time frame: Weeks 28
| Milestone | MASP+ App & NRT | QuitGuide App + NRT |
|---|---|---|
| Started | 39 | 37 |
| Completed | 39 | 37 |
| Not completed | 0 | 0 |
Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 weeks following the scheduled quit day. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of \< 7 ppm. Those with scores of 6 or below are biochemically confirmed to be abstinent.
| Participants | MASP+ App & NRT | QuitGuide App + NRT |
|---|---|---|
| Week 2 | 4 | 0 |
| Week 3 | 7 | 5 |
| Week 4 | 7 | 5 |
| Week 5 | 5 | 9 |
| Week 6 | 7 | 10 |
| Week 28 | 6 | 5 |
The Index of Engagement in HIV Care is a brief (10-item) self-report measure of engagement in human immunodeficiency virus (HIV) care. The total score is used to index engagement in HIV care, ranging from 10-50. Higher scores indicate greater engagement in HIV care.
| score on a scale | MASP+ App & NRT | QuitGuide App + NRT |
|---|---|---|
| Index of Engagement in HIV Care | 41.84 ± 9.47 | 42.85 ± 10.05 |
The World Health Organization Quality of Life HIV (WHOQOL-HIV) questionnaire is composed of 36 items and is used to index quality of life among respondents living with HIV/AIDS. The study use three subscales of the WHOQOL-HIV (physical domain \[range: 4-20\], psychological domain \[range: 4-25\], social relationships domain \[range: 4-20\]). All subscales are averaged and multiplied by 4. Higher scores on each substance indicate greater quality of life within the respective domain.
| score on a scale | MASP+ App & NRT | QuitGuide App + NRT |
|---|---|---|
| WHOQOL-HIV Physical Domain | 14.20 ± 3.30 | 13.40 ± 2.91 |
| WHOQOL-HIV Psychological Domain | 13.89 ± 3.39 | 12.88 ± 3.95 |
| WHOQOL-HIV Social Relationships Domain | 13.96 ± 4.17 | 14.30 ± 3.74 |
The 3-item Antiretroviral (ART) Adherence questionnaire is a brief scale used to assess frequency of missed ART medication doses and HIV care appointments among HIV+ patients/participants. The scale is averaged to create a score of ART adherence (range: 0-100), with greater scores indicate greater ART medication adherence.
| score on a scale | MASP+ App & NRT | QuitGuide App + NRT |
|---|---|---|
| Antiretroviral (ART) Adherence | 85.58 ± 17.88 | 91.47 ± 12.49 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MASP+ App & NRT | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| QuitGuide App + NRT | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Age, Continuous(years) | MASP+ App & NRT | QuitGuide App + NRT | Total |
|---|---|---|---|
| Mean | 47.05 ± 11.96 | 46.18 ± 10.30 | 46.63 ± 11.12 |
| Sex: Female, Male(Participants) | MASP+ App & NRT | QuitGuide App + NRT | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 31 | 30 | 61 |
| Race (NIH/OMB)(Participants) | MASP+ App & NRT | QuitGuide App + NRT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 39 | 37 | 76 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | MASP+ App & NRT | QuitGuide App + NRT | Total |
|---|---|---|---|
| United States | 39 | 37 | 76 |
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University of Houston